DSM breaks down EU regulatory pressures on industry regarding the safety of UV filters
29 Aug 2022 --- Royal DSM is spotlighting the European regulatory pressures faced by the industry regarding the safety of using UV filters on human health and the environment. This includes UV filter use in cosmetics which are evaluated under the EU Cosmetics Regulation and on human health and the environment assessed under Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
“While considering the environmental aspects is important, we must not neglect the strong positive societal impact of sun care products in terms of skin cancer prevention,” Michele Marchini, head of marketing sun protection at DSM tells PersonalCareInsights.
Moreover, DSM informs that the EC does not yet have specific provisions for endocrine disruptors (EDs). “However, it provides a regulatory framework to ensure a high level of protection of human health, laying down a system of restrictions on the use of certain substances in cosmetics,” it continues.
Last month, an amendment was passed by the European Commission (EC) to limit the use of UV filters in cosmetics owing to their potential impacts on consumer health, giving companies a maximum of one year to implement the changes in their products to meet the requirements.
Chemical substances that alter the functioning of the hormonal health system and adversely affect the health of humans are known as endocrine disruptors. “Insufficient” data a decade later
Chemical substances that alter the function of the endocrine or hormonal health system and adversely affect the health of humans and animals are known as endocrine disruptors, as stated by DSM.
The 2013 report titled State of the Science of Endocrine Disrupting Chemicals, published by the United Nations Environment Programme and WHO was touted to be a “landmark” in highlighting the associations between exposure to EDs and health problems.
The effects of human exposure to hormone-disrupting chemicals include the potential for the development of undescended testes in young males, breast cancer in women, prostate cancer in men, developmental effects on the nervous system in children, attention deficit or hyperactivity in children and thyroid cancer, as per the report.
“We urgently need more research to obtain a fuller picture of the health and environment impacts of endocrine disruptors,” said Dr. Maria Neira, WHO’s Director for Public Health and Environment, at the time.
Lacking standardized regulation
Almost a decade later, there still seems to be insufficient data to ban UV filters entirely.
“Measuring the impact of UV filters on the marine environment such as corals is an important topic, with unfortunately no standardized methods being available and very few relevant test institutes that are able to grow those delicate species under healthy lab conditions,” Dr. Jochen Klock, head of global regulatory and quality personal care and aroma at DSM, tells PersonalCareInsights.
On the other hand, cosmetic bodies like the Personal Care Products Council (PCPC) previously stated the importance of using sunscreens to protect skin health.
“Policymakers, regulators and legislators should not make any decisions that impact consumers’ access to FDA-approved sunscreen UV filters until the scientific community reaches an informed consensus,” the PCPC stated regarding a report calling for more scientific study on the use of sunscreens and their implication on aquatic environments.
“The key conclusions [of the report] confirm PCPC’s long-held position that there is currently insufficient relevant and reliable scientific data to conduct realistic ecological risk assessments (ERA), and there is not enough scientific data to support sunscreen ingredient bans.”
Regulatory developments
EC put out a priority list of 28 potential EDs for call for data.
DSM informs that on 7 November 2018, the EC reported a review of Regulation No 1223/2009 of the European Parliament and the Council of 30 November 2009 on cosmetic products (the Cosmetics Regulation) regarding suspected endocrine-disrupting substances.
The EU also revised the Classification, Labeling and Packaging (CLP) of Substances and Mixtures, which outlines the use of chemicals, 12 relevant for cosmetics use and six classified as carcinogenicity, mutagenicity and reproductive toxicity.
“Potential endocrine-disrupting substances are in scope of a scientific risk assessment by the Scientific Committee on Consumer Safety (SCCS) as laid down in the ‘SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation’ (NoG),” states DSM.
EC put out a priority list of 28 potential EDs for call for data. “The SCCS’s risk assessment addresses scientific concerns about the endocrine-disrupting properties of each substance in cosmetics, and judges whether endocrine/hormonal activities are linked to critical endpoints to assess the safety of the substances for consumers,” according to DSM.
Based on the data provided by the European Federation for Cosmetic Ingredients, UV filter consortium members and Cosmetics Europe, with the conclusion of the consultation period and opinions from the SCCS this August, there will be a two-month grace period for further comments from data contributors and the wider industry.
By Radhika Sikaria
